U.S. patent number 11,045,315 [Application Number 15/662,098] was granted by the patent office on 2021-06-29 for methods of steering and delivery of intravascular devices.
This patent grant is currently assigned to CEPHEA VALVE TECHNOLOGIES, INC.. The grantee listed for this patent is Cephea Valve Technologies, Inc.. Invention is credited to Sean A. McNiven, Francisco Valencia, Randolf von Oepen.
United States Patent |
11,045,315 |
Valencia , et al. |
June 29, 2021 |
Methods of steering and delivery of intravascular devices
Abstract
A method of delivering a rigid intravascular device to a target
location in a patient's heart includes positioning a distal tip of
an elongated member of the intravascular device delivery system in
a right atrium of a heart and moving the distal tip of the
elongated member into a left atrium of the heart. The method
includes advancing an inner steerable catheter of the elongated
member longitudinally distally relative to an outer sleeve of the
elongated member a first longitudinal distance; deflecting at least
a portion of the inner steerable catheter a first deflection
amount; then advancing an inner steerable catheter of the elongated
member longitudinally distally relative to an outer sleeve of the
elongated member a second longitudinal distance; and then
deflecting at least a portion of the inner steerable catheter a
second deflection amount.
Inventors: |
Valencia; Francisco (East Palo
Alto, CA), McNiven; Sean A. (Menlo Park, CA), von Oepen;
Randolf (Aptos, CA) |
Applicant: |
Name |
City |
State |
Country |
Type |
Cephea Valve Technologies, Inc. |
Santa Clara |
CA |
US |
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Assignee: |
CEPHEA VALVE TECHNOLOGIES, INC.
(Santa Clara, CA)
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Family
ID: |
1000005642811 |
Appl.
No.: |
15/662,098 |
Filed: |
July 27, 2017 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20180055636 A1 |
Mar 1, 2018 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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62436913 |
Dec 20, 2016 |
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62380862 |
Aug 29, 2016 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F
2/2427 (20130101); A61F 2/24 (20130101); A61M
25/0147 (20130101); A61M 25/0138 (20130101) |
Current International
Class: |
A61F
2/24 (20060101); A61M 25/01 (20060101) |
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Primary Examiner: Gabr; Mohamed G
Attorney, Agent or Firm: Workman Nydegger
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims the benefit of and priority to U.S.
Provisional Patent Application Ser. No. 62/380,862 filed on Aug.
29, 2016 and entitled "Methods of Steering and Delivery of
Intravascular Devices," and to U.S. Provisional Patent Application
Ser. No. 62/436,913 filed on Dec. 20, 2016 and entitled "Methods of
Steering and Delivery of Intravascular Devices," which applications
are expressly incorporated herein by reference in their entirety.
Claims
What is claimed is:
1. A method of positioning an intravascular device delivery system
at a target location, the method comprising: positioning a portion
of an elongated member within a vena cava, a first bend portion of
the elongated member being near a distal tip of the elongated
member and a second bend portion of the elongated member being
proximal the first bend portion, the second bend portion being
disposed within the vena cava and bending in a direction opposite
to the first bend portion; positioning a distal tip of the
elongated member of the intravascular device delivery system in a
right atrium of a heart, the distal tip being urged toward a wall
of the right atrium of the heart by the combination of the first
bend portion and the second bend portion; moving the distal tip of
the elongated member into a left atrium of the heart while the
second bend portion is within the vena cava and the first bend
portion is within the right atrium; moving an inner steerable
catheter of the elongated member relative to an outer sleeve of the
elongated member, the inner steerable catheter steering the outer
sleeve of the elongated member; deflecting at least a portion of
the inner steerable catheter a first deflection amount within the
left atrium towards a mitral annulus; and deflecting at least a
portion of the inner steerable catheter a second deflection amount
within the left atrium towards the mitral annulus.
2. The method of claim 1, further comprising advancing the inner
steerable catheter of the elongated member longitudinally distally
relative to the outer sleeve of the elongated member a first
longitudinal distance and deflecting at least the portion of the
inner steerable catheter the first deflection amount at least
partially simultaneously.
3. The method of claim 2, further comprising advancing the inner
steerable catheter of the elongated member longitudinally distally
relative to the outer sleeve of the elongated member a second
longitudinal distance and deflecting at least the portion of the
inner steerable catheter the second deflection amount at least
partially simultaneously.
4. The method of claim 3, wherein the second longitudinal distance
is less than 10 millimeters.
5. The method of claim 2, wherein the first longitudinal distance
is less than 10 millimeters.
6. The method of claim 1, wherein the first deflection amount is
less than 90.degree..
7. The method of claim 1, wherein the second deflection amount is
less than 90.degree..
8. The method of claim 1, wherein moving the distal tip of the
elongated member in the left atrium of the heart further comprises
positioning a distal tip of the outer sleeve of the elongated
member in the left atrium within 10 mm of an intra-atrial
septum.
9. The method of claim 1, further comprising deflecting the outer
sleeve in a direction opposite to a direction of the distal tip of
the elongated member of the intravascular device delivery system in
the right atrium of the heart.
10. The method of claim 1, further comprising deflecting the outer
sleeve at a location proximal a distal location about which the
distal tip of the elongated member of the intravascular device
delivery system deflects to position the distal tip in the right
atrium of the heart.
11. A method of positioning an intravascular device delivery system
at a target location, the method comprising: positioning a
replacement valve in a right atrium of a heart, the replacement
valve located at a distal end of an elongated member of the
intravascular device delivery system and distal a distal end of an
inner steerable catheter disposed within an outer sleeve of the
elongated member, wherein positioning the replacement valve
comprises positioning a portion of the elongated member within a
vena cava, a first bend portion of the elongated member being near
the distal end of the elongated member and a second bend portion of
the elongated member being proximal the first bend portion, the
second bend portion being disposed within the vena cava and bending
in a direction opposite to the first bend portion to urge a portion
of the first bend portion toward a wall of the right atrium of the
heart at a junction of the vena cava and the right atrium; moving a
distal tip of the elongated member into a left atrium of the heart
while the second bend portion is within the vena cava and the first
bend portion is within the right atrium; moving the replacement
valve into the left atrium of the heart; deflecting at least a
portion of the inner steerable catheter a first deflection amount
within the left atrium towards a mitral annulus; deflecting at
least a portion of the inner steerable catheter a second deflection
amount within the left atrium towards the mitral annulus; and
deploying the replacement valve at the target location.
12. The method of claim 11, further comprising advancing the inner
steerable catheter of the elongated member longitudinally distally
relative to the outer sleeve of the elongated member a first
longitudinal distance and deflecting at least the portion of the
inner steerable catheter the first deflection amount at least
partially simultaneously.
13. The method of claim 12, further comprising advancing the inner
steerable catheter of the elongated member longitudinally distally
relative to the outer sleeve of the elongated member a second
longitudinal distance and deflecting at least the portion of the
inner steerable catheter the second deflection amount at least
partially simultaneously.
14. The method of claim 13, wherein the second longitudinal
distance is less than 6 millimeters.
15. The method of claim 12, wherein the first longitudinal distance
is less than 6 millimeters.
16. The method of claim 11, wherein a longitudinal length of the
replacement valve is greater than 10 millimeters.
17. The method of claim 11, wherein the first deflection amount is
less than 45.degree..
18. The method of claim 11, wherein the second deflection amount is
less than 45.degree..
19. The method of claim 11, wherein moving the distal tip of the
elongated member in the left atrium of the heart further comprises
positioning a distal tip of the outer sleeve of the elongated
member in the left atrium within 10 mm of an intra-atrial
septum.
20. The method of claim 11, further comprising deflecting the outer
sleeve in a direction opposite to a direction of movement of the
distal tip of the elongated member of the intravascular device
delivery system in the right atrium of the heart.
21. The method of claim 11, further comprising deflecting the outer
sleeve at a location proximal a distal location about which the
distal tip of the elongated member of the intravascular device
delivery system deflects to position the distal tip in the right
atrium of the heart.
22. A method of positioning an intravascular device delivery system
at a target location, the method comprising: positioning a
replacement valve in a right atrium of a heart, the replacement
valve located at a distal end of an elongated member of the
intravascular device delivery system and the replacement valve
having a longitudinal length at least 10 millimeters, wherein
positioning the replacement valve comprises positioning a portion
of the elongated member within a vena cava, a first bend portion of
the elongated member being near the distal end and a second bend
portion of the elongated member being proximal the first bend
portion, the second bend portion bending in a direction opposite to
the first bend portion to urge the elongate body near the first
bend portion toward a wall of the right atrium of the heart; moving
the rigid intravascular device into a left atrium of the heart
through an intra-atrial septum while the second bend portion is
within the vena cava and the first bend portion is within the right
atrium; moving an inner steerable catheter of the elongated member
relative to an outer sleeve of the elongated member with the
replacement valve disposed distal a distal end of the inner
steerable catheter; deflecting at least a portion of the inner
steerable catheter a first deflection amount within the left atrium
towards a mitral annulus; deflecting at least the portion of the
inner steerable catheter a second deflection amount within the left
atrium towards the mitral annulus; longitudinally positioning the
inner steerable catheter of the elongated member relative to the
outer sleeve of the elongated member a first longitudinal distance
within the left atrium; and deploying the replacement valve at the
target location.
Description
BACKGROUND OF THE DISCLOSURE
Intravascular medical procedures allow the performance of
therapeutic treatments in a variety of locations within a patient's
body while requiring only relatively small access incisions. An
intravascular procedure may, for example, eliminate the need for
open-heart surgery, reducing risks, costs, and time associated with
an open-heart procedure. The intravascular procedure also enables
faster recovery times with lower associated costs and risks of
complication. An example of an intravascular procedure that
significantly reduces procedure and recovery time and cost over
conventional open surgery is a heart valve replacement or repair
procedure. An artificial valve is guided to the heart through the
patient's vasculature. For example, a catheter is inserted into the
patient's vasculature and directed to the inferior vena cava. The
catheter is then urged through the inferior vena cava toward the
heart by applying force longitudinally to the catheter. Upon
entering the heart from the inferior vena cava, the catheter enters
the right atrium. The distal end of the catheter may be deflected
by one or more wires positioned inside the catheter. Precise
control of the distal end of the catheter allows for more reliable
and faster positioning of a medical device and/or implant and other
improvements in the procedures.
The devices can also be directed through the valve chordae or
papillary muscles, for example, for interventional therapy to the
mitral valve. When such procedures require the use of more than one
instrument, each instrument would be dependent upon proper
positioning in relation to the valve. Therefore, positioning or
steering mechanisms need to be built into each instrument. This
adds further cost, complexity, and time to the procedures.
Other procedures may include tracking a catheter and/or access
sheath from a puncture in the femoral vein through the intra-atrial
septum to the left atrium. This pathway may be used to access the
left atrium for ablation of the atrium wall or ablation around the
pulmonary veins. Such interventional therapies would require
precise alignment with target areas for proper ablation placement.
Additionally, alternative access routes and/or access routes to
other cavities may be desired.
The scope of intravascular procedures has increased in recent years
with more intravascular devices delivered to the heart through the
patient's vasculature. Intravascular device delivery utilizes
comparatively small radius turns through torturous anatomy that
limits the capacity of the intravascular device delivery system to
deliver intravascular devices of different dimensions.
BRIEF SUMMARY OF THE DISCLOSURE
In an embodiment, a method of delivering an intravascular device
includes positioning a distal tip of an elongated member of the
intravascular device delivery system in a right atrium of a heart;
moving the distal tip of the elongated member into a left atrium of
the heart; advancing an inner steerable catheter of the elongated
member longitudinally distally relative to an outer sleeve of the
elongated member a first longitudinal distance; deflecting at least
a portion of the inner steerable catheter a first deflection
amount; advancing an inner steerable catheter of the elongated
member longitudinally distally relative to an outer sleeve of the
elongated member a second longitudinal distance; and deflecting at
least a portion of the inner steerable catheter a second deflection
amount.
This summary is provided to introduce a selection of concepts that
are further described below in the detailed description. This
summary is not intended to identify specific features of the
claimed subject matter, nor is it intended to be used as an aid in
limiting the scope of the claimed subject matter.
Additional features of embodiments of the disclosure will be set
forth in the description that follows. The features of such
embodiments may be realized by means of the instruments and
combinations particularly pointed out in the appended claims. These
and other features will become more fully apparent from the
following description and appended claims, or may be learned by the
practice of such exemplary embodiments as set forth
hereinafter.
BRIEF DESCRIPTION OF THE DRAWINGS
In order to describe the manner in which the above-recited and
other features of the disclosure can be obtained, a more particular
description will be rendered by reference to specific embodiments
thereof that are illustrated in the appended drawings. For better
understanding, the like elements have been designated by like
reference numbers throughout the various accompanying figures.
While some of the drawings may be schematic or exaggerated
representations of concepts, at least some of the drawings may be
drawn to scale. Understanding that the drawings depict some example
embodiments, the embodiments will be described and explained with
additional specificity and detail through the use of the
accompanying drawings in which:
FIG. 1 is a schematic representation of an intravascular device
delivery system delivering a flexible intravascular device in a
heart;
FIG. 2-1 is a flowchart illustrating an embodiment of a method of
positioning a rigid intravascular device in a heart;
FIG. 2-2 is a flowchart illustrating an embodiment of a method of
delivering a rigid intravascular device in an operating setting to
a target location in a heart;
FIG. 3 is a schematic partial cutaway diagram of an embodiment of a
rigid intravascular device positioned at a distal end of an
elongated member of an intravascular device delivery system;
FIG. 4 is a cross-sectional view of the embodiment of an
intravascular device delivery system of FIG. 3 in a right
atrium;
FIG. 5 is a cross-sectional view of the embodiment of an
intravascular device delivery system of FIG. 3 in a left
atrium;
FIG. 6-1 is a cross-sectional view of the embodiment of an
intravascular device delivery system of FIG. 3 with the inner
steerable catheter translated axial from the outer steerable
catheter;
FIG. 6-2 is a cross-sectional view of the embodiment of an
intravascular device delivery system of FIG. 3 with a bend in the
inner steerable catheter; and
FIG. 7 is a cross-sectional view of the embodiment of an
intravascular device delivery system of FIG. 3 with the
intravascular device positioned at the mitral valve.
FIG. 8A graphically depicts a path generally taken by a
conventional delivery catheter through the right atrium of the
heart and through the intra-atrial septum.
FIG. 8B graphically depicts an improved path for the delivery
catheter by use of various cut patterns in different sections of
the delivery catheter.
FIG. 9 is a graphical representation of various cut patterns that
can be used in different sections of the delivery catheter to
achieve a desired shape or bending of the delivery catheter.
FIG. 10 is a cross-sectional view of an inner steering
catheter.
DETAILED DESCRIPTION
One or more specific embodiments of the present disclosure will be
described below. In an effort to provide a concise description of
these embodiments, some features of an actual embodiment may be
described in the specification. It should be appreciated that in
the development of any such actual embodiment, as in any
engineering or design project, numerous embodiment-specific
decisions will be made to achieve the developers' specific goals,
such as compliance with system-related and business-related
constraints, which may vary from one embodiment to another. It
should further be appreciated that such a development effort might
be complex and time consuming, but would nevertheless be a routine
undertaking of design, fabrication, and manufacture for those of
ordinary skill having the benefit of this disclosure.
One or more embodiments of the present disclosure may generally
relate to manufacturing and using intravascular device delivery
systems or other steerable intravascular systems. An intravascular
device delivery system may allow a medical professional to deliver
an intravascular or other medical device to a target location in a
patient's body. While the present disclosure will describe
intravascular device delivery systems and applications thereof in
relation to intravascular procedures in the heart, it should be
understood that the devices, systems, and methods described herein
may be applicable to other bodily lumens and/or cavities.
Additionally, elements described in relation to any embodiment
depicted and/or described herein may be combinable with elements
described in relation to any other embodiment depicted and/or
described herein. For example, any element described in relation to
an embodiment depicted in FIG. 1 may be combinable with any element
of an embodiment described in FIG. 3, and any element described in
relation to an embodiment described in FIG. 6-2 may be combinable
with any element of an embodiment depicted in FIG. 3.
An intravascular device delivery system includes a flexible
elongated member that has a distal end and a proximal end. A handle
is connected to a proximal end of the elongated member to allow a
user, such as a medical professional and/or clinician, to control
one or more movements of the elongated member. An intravascular
device is positioned at and/or connected to the distal end of the
elongated member.
In some embodiments, the elongated member includes a plurality of
elements. For example, the elongated member may include a plurality
of elements that extend from the proximal end to the distal end. In
some embodiments, at least one of the elements of the elongated
member includes a plurality of lumens therethrough to allow
steerability of the element. In at least one embodiment, at least
one element of the elongated member is steerable in at least two
planes.
In some embodiments, the handle may include one or more controls
(e.g., a knob, a button, a lever, or other controls) that may move
at least one part of the intravascular device delivery system
relative to another. For example, the handle may include one or
more controls for moving at least one element of the elongated
member relative to another element of the elongated member. The
handle may move an inner element relative to an outer element of
the elongated member in a proximal direction, in a distal
direction, in a rotational direction, or combinations thereof.
FIG. 1 illustrates an intravascular device delivery system 100 that
includes an elongated member 102 with a distal tip 104 positioned
proximate a target location, such as the mitral annulus 106 of the
heart. The intravascular device delivery system 100 includes the
elongated member 102 and an intravascular device 108 that is
deliverable through the elongated member 102 to the target
location.
The elongated member 102 of the intravascular device delivery
system 100 is steerable to the distal tip 104, allowing the distal
tip 104 to be located at the target location after entering the
left atrium 110 of the heart. A intravascular device 108 is then
urged longitudinally through the elongated member 102 to the distal
tip 104 and is deployed at the target location. The confines of the
left atrium 110, however, may limit the mobility of a rigid
intravascular device once the rigid intravascular device is within
the left atrium 110.
FIG. 2-1 is a flowchart 212 illustrating an embodiment of a method
of positioning a rigid intravascular device at a target location in
a patient's heart. In some embodiments, the method includes
positioning 214 a rigid intravascular device distal the distal tip
of an elongated member of an intravascular device delivery system.
The method further includes moving 216 the rigid intravascular
device and elongated member together through the intra-atrial
septum and into the left atrium.
The method further includes advancing 218 the rigid intravascular
device and an inner steerable catheter relative to an outer sleeve
of the elongated member while deflecting 220 the inner steerable
catheter toward the mitral annulus. In some embodiments, advancing
218 the rigid intravascular device and deflecting 220 the inner
steerable catheter occur simultaneously. In other embodiments,
advancing 218 the rigid intravascular device and inner steerable
catheter and deflecting 220 the inner steerable catheter occur in
an alternating, iterative fashion (e.g., advancing 218 the
replacement valve and inner steerable catheter a first time,
deflecting 220 the inner steerable catheter a first time, advancing
218 the replacement valve and inner steerable catheter a second
time, and deflecting 220 the inner steerable catheter a second
time). An operator may advance the rigid intravascular device and
inner steerable catheter and deflect the inner steerable catheter
as many times as necessary to position the rigid intravascular
device at the target location before deploying the rigid
intravascular device.
In at least one embodiment, the method further includes advancing
the outer sleeve relative to the intra-atrial septum after
deflecting 220 the inner steerable catheter to orient the rigid
intravascular device toward and/or in the mitral annulus.
FIG. 2-2 is a flowchart illustrating an embodiment of a more
complete operative method of delivering a replacement valve
intravascular device, according to the present disclosure. For
example, the embodiment illustrated includes loading 307 the valve
onto a distal tip of an elongated member (such as distal tip 104 of
elongated member 102 described herein) and inserting 309 the
intravascular device delivery system and replacement valve into the
patient's vein.
Loading a replacement valve onto and/or into a distal tip of an
elongated member may include rinsing the valve or other
intravascular device in sterile water or saline. After removing
storage or transportation fluids or other coatings from the
replacement valve, the device is collapsed in a radial direction to
a collapsed state during loading. The replacement valve may be
immersed the valve in a cold water or saline bath. For example, a
replacement valve with one or more shape-memory material components
may be biased to expand radially at room and/or body temperature.
The cold water or saline bath lowers the temperature of the
replacement valve below a transformation temperature of the device,
easing the transition to the collapsed state of the device.
The replacement valve may be loaded in to a loading device, such as
a cone or other tapered structure. At least a portion of the
elongated member of the intravascular device delivery system (e.g.,
a guidewire and/or guidewire lumen with an atraumatic tip) is
inserted through the valve and distally beyond the valve such that
the portion of the elongated member of the intravascular device
delivery system extends completely through the replacement valve.
The loading device is then advanced over the replacement valve to
radially compress the replacement valve without folding or creasing
the replacement valve. In at least one embodiments, an outer sleeve
of the elongated member is moved in a distal direction (i.e.,
toward the replacement valve) to capture the collapsed replacement
valve and retain the replacement valve in the distal tip of the
elongated member.
As described herein, the intravascular device may be loaded into
the patient's femoral artery to provide vascular access to the
heart by advancing 311 the intravascular device delivery system
through the femoral vein and into the heart via the inferior vena
cava.
Once positioned in the right atrium of the heart, the intravascular
device delivery system is oriented in the heart and toward the
intra-atrial septum by deflecting 313 a steerable guide sheath of
the elongated member and torquing 315 the steerable guide sheath.
The intravascular device delivery system is oriented by iteratively
and/or simultaneously deflecting 313 and torquing 315 the steerable
guide sheath until the distal tip and/or guidewire of the
intravascular system is properly oriented with respect to the
intra-atrial septum.
The intravascular device (i.e., the replacement valve) is
positioned into the left atrium of the heart by advancing 317 the
inner steerable catheter relative to the steerable guide sheath and
torquing 319 the steerable guide sheath. Similar to deflecting 313
and torquing 315 the steerable guide sheath described above,
advancing 317 the inner steerable catheter relative to the
steerable guide sheath and torquing 319 the steerable guide sheath
may be performed iteratively and/or simultaneously until the
replacement valve is positioned in the right atrium and the bending
plane of the inner steerable catheter is aligned with the target
location in the heart (e.g., the mitral annulus).
The method further includes advancing 318 the rigid intravascular
device and an inner steerable catheter relative to a steerable
guide sheath of the elongated member while deflecting 320 the inner
steerable catheter toward the mitral annulus. In some embodiments,
advancing 318 the replacement valve and deflecting 320 the inner
steerable catheter occur simultaneously. In other embodiments,
advancing 318 the replacement valve and inner steerable catheter
and deflecting 320 the inner steerable catheter occur in an
alternating, iterative fashion (e.g., advancing 318 the replacement
valve and inner steerable catheter a first time, deflecting 320 the
inner steerable catheter a first time, advancing 318 the
replacement valve and inner steerable catheter a second time, and
deflecting 320 the inner steerable catheter a second time). An
operator may advance the rigid intravascular device and inner
steerable catheter and deflect the inner steerable catheter as many
times as necessary to position the replacement valve above the
target location before advancing 321 the catheter to center the
replacement valve in the target location and at least partially
deploying 323 the replacement valve from the intravascular device
delivery system.
At least one illustrative embodiment of the method shown in FIG.
2-1 and part of the method shown in FIG. 2-2 is depicted in FIG. 3
through FIG. 7. FIG. 3 is a side view of an intravascular device
delivery system 300, according to the present disclosure. The rigid
intravascular device 308 is shown positioned at (e.g., in contact
with) the distal tip 304 of the elongated member 302 of the
intravascular device delivery system 300. In some embodiments, the
rigid intravascular device 308 has a longitudinal length of 10
millimeters (mm), 20 mm, 30 mm, 40 mm, 50 mm, or any length
therebetween that is substantially rigid. For example, the rigid
intravascular device 308 may have at least 10 mm of the rigid
intravascular device 308 that is rigid and may not pass through a
curved catheter. Therefore, the rigid intravascular device 308 is
positioned at the distal tip 304 of the elongated member 302 and is
advanced through the patient's vasculature at the distal tip 304 of
the elongated member 302 and/or at least partially external to the
elongated member 302.
FIG. 3 also illustrates a plurality of elements in the elongated
member 302. In some embodiments, the elongated member 302 includes
at least an outer sleeve 324 and an inner steerable catheter 326
positioned radially within the outer sleeve 324. The inner
steerable catheter 326 may have a lumen 328 therethrough that may
allow a guidewire 330 to be moved longitudinally through the
elongated member 302. In some embodiments, the rigid intravascular
device 308 is positioned at the distal end of the inner steerable
catheter 326. In other embodiments, the rigid intravascular device
308 is connected to the distal end of the inner steerable catheter
326.
In some embodiments, the outer sleeve 324 is a steerable catheter,
such as a steerable guide catheter, that is steerable in at least
one plane. In other embodiments, the outer sleeve 324 is steerable
in at least two planes. In yet other embodiments, the outer sleeve
324 is not steerable and steering of the elongated member 302
relies upon the inner steerable catheter 326 and/or other elements
of the elongated member 302.
FIG. 4 illustrates the embodiment of an elongated member 302 and
rigid intravascular device 308 of FIG. 3 positioned in a right
atrium 332 of a heart 334. A guidewire 330 may be inserted through
the intra-atrial septum and into the left atrium 310 of the heart
334. The rigid intravascular device 308 is then urged
longitudinally through the intra-atrial septum 322 to the left
atrium 310, as shown in FIG. 5.
FIG. 5 shows the embodiment of an elongated member 302 and rigid
intravascular device 308 of FIG. 3 positioned in left atrium 310 of
the heart 334. In some embodiments, the target location is the
mitral annulus 306. The rigid intravascular device 308 may have a
longitudinal length such that the rigid intravascular device 308
strikes the wall of the left atrium 310 opposite the intra-atrial
septum 322 if the distal tip 304 of the elongated member 302 is
positioned over the mitral annulus 306 before deflecting the
elongated member 302.
In some embodiments, the elongated member 302 is advanced until the
distal tip of the outer sleeve 324 is positioned just beyond the
intra-atrial septum in the left atrium 310, such that the rigid
intravascular device 308 is in the left atrium 310 and little to no
longitudinal length of the outer sleeve 324 is in the left atrium
310. For example, less than 5 mm, less than 4 mm, less than 3 mm,
less than 2 mm, or less than 1 mm of the outer sleeve 324 may be
located in the left atrium 310.
As shown in FIG. 6-1, the rigid intravascular device 308 may be
deflected toward the target location (e.g., downward toward the
mitral annulus 306). The rigid intravascular device 308 may be
deflected by steering the inner steerable catheter 326 toward the
target location, by steering the outer sleeve 324 toward the target
location, or a combination thereof. The rigid intravascular device
308 may be deflected by a deflection angle 336 in a range having an
upper value, a lower value, or an upper and lower value including
any of 5.degree., 10.degree., 15.degree., 20.degree., 25.degree.,
30.degree., 35.degree., 40.degree., 45.degree., 50.degree.,
55.degree., 60.degree., 65.degree., 70.degree., 75.degree.,
80.degree., 85.degree., 90.degree., 95.degree., 100.degree., or any
values therebetween. For example, the deflection angle 336 may be
greater than 5.degree.. In other examples, the deflection angle 336
may be less than 100.degree.. In yet other examples, the deflection
angle 336 may be between 5.degree. and 100.degree.. In further
examples, the deflection angle 336 may be between 10.degree. and
90.degree..
FIG. 6-2 illustrates the rigid intravascular device 308 and inner
steerable catheter 326 being advanced relative to the outer sleeve
324. The inner steerable catheter 326 is moved longitudinally
through the outer sleeve 324 such that the rigid intravascular
device 308 moves distally and away from the outer sleeve 324. A
deflection portion 338 of the inner steerable catheter 326 is
located at or near the distal tip of the inner steerable catheter
326 such that longitudinal movement of the inner steerable catheter
326 moves the deflection portion 338 relative to at least one of
the outer sleeve 324, the intra-atrial septum, and the mitral
annulus 306.
In some embodiments, the inner steerable catheter 326 is advanced
relative to the outer sleeve 324 a longitudinal distance 340 in a
range having an upper value, a lower value, or an upper and lower
value including any of 0.5 mm, 1.0 mm, 1.5 mm, 2.0 mm, 2.5 mm, 3.0
mm, 3.5 mm, 4.0 mm, 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 6.5 mm, 7.0 mm,
7.5 mm, 8.0 mm, 8.5 mm, 9.0 mm, 9.5 mm, 10.0 mm, or any values
therebetween. For example, the inner steerable catheter 326 is
advanced relative to the outer sleeve 324 a longitudinal distance
340 greater than 0.5 mm. In other examples, the inner steerable
catheter 326 is advanced relative to the outer sleeve 324 a
longitudinal distance 340 less than 10 mm. In yet other examples,
the inner steerable catheter 326 is advanced relative to the outer
sleeve 324 a longitudinal distance 340 in a range between 0.5 mm
and 10 mm.
After advancing the inner steerable catheter 326 relative to the
outer sleeve 324, the rigid intravascular device 308 may be
deflected toward the target location (e.g., downward toward the
mitral annulus 306) a second time, similar to as described in
relation to FIG. 6-1. In some embodiments, the rigid intravascular
device 308 is deflected a second deflection amount that is greater
than the first deflection amount of the first time. In other
embodiments, the rigid intravascular device 308 is deflected a
second deflection amount that is less than the first deflection
amount of the first time. In yet other embodiments, the rigid
intravascular device 308 is deflected a second deflection amount
that is equivalent to the first deflection amount of the first
time.
In some embodiments, after the rigid intravascular device 308 is
deflected a second time, the inner steerable catheter 326 is
advanced relative to the outer sleeve 324 a second time, similar to
as described in relation to FIG. 6-2. In some embodiments, the
inner steerable catheter 326 is advanced relative to the outer
sleeve 324 a second longitudinal distance that is greater than the
first longitudinal distance of the first time. In other
embodiments, the inner steerable catheter 326 is advanced relative
to the outer sleeve 324 a second longitudinal distance that is less
than the first longitudinal distance of the first time. In yet
other embodiments, the inner steerable catheter 326 is advanced
relative to the outer sleeve 324 a second longitudinal distance
that is equivalent to the first longitudinal distance of the first
time.
In at least one embodiment, deflecting the rigid intravascular
device 308 and advancing the inner steerable catheter 326 relative
to the outer sleeve 324 are at least partially simultaneous. For
example, an operator may deflect the rigid intravascular device 308
while advancing the inner steerable catheter 326 relative to the
outer sleeve 324.
An operator may deflect the rigid intravascular device 308 and
advance the inner steerable catheter 326 relative to the outer
sleeve 324 until the rigid intravascular device 308 is positioned
at the target location, as shown in FIG. 7. In at least one
embodiment, the target location is the mitral annulus 306 of the
heart. Once positioned at the target location, the rigid
intravascular device 308 may be oriented substantially normal to
the mitral annulus 306 by rotational deflection of the inner
steerable catheter 326 relative to the outer sleeve 324.
In some embodiments, the rigid intravascular device 308 may be
deployed at the target location and subsequently remain in the
patient's body. In other embodiments, the rigid intravascular
device 308 may be used to perform a therapeutic procedure at the
target location and be subsequently removed from the patient's
body.
The right atrium 332 of a human heart 334 provides limited space in
which to bend or steer a catheter from the direction in which the
inferior vena cava enters the heart to a direction in line with the
intra-atrial septum separating the right atrium 332 from the left
atrium 333. And, the longer an intravascular device 308 is, the
more difficult it can be to make the necessary bend within the
confines of the right atrium 332. For example, FIG. 8A graphically
depicts a path generally taken by a conventional delivery catheter
through the right atrium 332 and through the intra-atrial
septum.
To address that issue, the steerable outer sleeve 324 can produce a
first bend at a first location 350 near a distal end of the
steerable outer sleeve 324, while also producing a second bend at a
second location 352 proximal the first location 350. This can
provide an improved path for the delivery catheter, as graphically
illustrated in FIG. 8B, that can provide additional space in which
to allow the distal end portion of the catheter and intravascular
device to make the turn within the right atrium. As mentioned
above, the outer sleeve 324 can have various alternate
configurations. In some embodiments, the outer sleeve 324 is a
steerable catheter, such as a steerable guide catheter, that is
steerable in at least one plane. For instance, in one
configuration, the steerable outer sleeve 324 can bend or steer in
two different directions within the same plane to aid positioning
the elongated member 324 along the vena cava, as illustrated in
FIGS. 8-10, to position the distal tip within the right atrium of
the heart in preparation for advancement of the rigid intravascular
device 308 through the intra-atrial septum and steering towards a
deployment location in the left atrium of the heart. The second
bend at the second location 352 can be in a direction opposite to
that of the first bend at the first location 350. By so doing, the
second bend pushes or "kicks" the steerable outer sleeve 324, and
more generally the catheter, in the opposite direction from the
movement of the distal tip near the first location 350. This
movement urges the catheter near the first bend location 350 to
move toward the wall of the right atrium 332 of the heart 334 and
creates more space for the distal tip of the catheter (i.e., a
distal portion of elongated member 302 and the rigid intravascular
device 308) to bend and penetrate the intra-atrial septum.
The steerable outer sleeve 324 can be a hypotube, either based on
stainless steel or Nitinol. Different sections of the hypotube can
be cut in a way that causes that section to bend only in one,
desired plane. As illustrated in FIG. 9, various cutting patterns
can be used can be used in different sections or regions of the
steerable outer sleeve 324 to produce the desired bends and
locations 350 and 352. Each section can include cut patterns that
can include one or more slits 356 and/or one or more island cuts
358. The slits 356 may transmit longitudinal force along the
steerable outer sleeve 324 and allow expansion of the flexible
steerable outer sleeve 324 when the flexible steerable outer sleeve
324 is deflected in a direction opposite the slit 356. The island
cuts 358 may allow compression of the flexible steerable outer
sleeve 324 when the flexible steerable outer sleeve 324 is
deflected in a direction of the island cuts 358. For example, slits
356 and island cuts 358, when located on opposite sides from one
another on a flexible steerable outer sleeve 324 may direct
preferential bending of the steerable outer sleeve 324 along a
center line of the island cuts 358.
In one embodiment, illustrated in FIG. 9, the cutting pattern
formed in steerable outer sleeve 324 can include five sections or
regions 360, 362, 364, 366 and 368, with different cut patterns in
each section. For example, in the embodiment illustrated in FIG. 9:
first section 360 can be approximately 2.5 mm in length and can
consist of a plurality of holes radially spaced about the periphery
of the steerable outer sleeve 324; second section 362 can be
approximately 25 mm in length and can consist of approximately 43
slits and island cuts; third section 364 can be approximately 8 mm
in length and can consist of approximately 14 slits and island
cuts; fourth section 366 can be approximately 30.5 mm in length and
can consist of an uncut distal portion that can be approximately 7
mm in length, a cut portion that can be approximately 35 mm in
length and can include approximately 21 slits and island cuts and
an uncut proximal portion that can be approximately 2.5 mm in
length; and fifth section 368 can be approximately 570 mm in length
and can consist of approximately 228 slits. While the island cuts
358 are depicted in FIG. 9 as diamond-shaped, the island cuts 358
may have one or more other shapes, such as square, rhombohedral,
triangular, rectangular, circular, oblong, other elliptical, other
polygonal, irregular, or combinations thereof.
To force the steerable outer sleeve 324 to bend, tension cables 372
can extend to rings 370 placed at different locations of the
steerable outer sleeve 324. For instance, the tension cables 372
can be placed on an outside of the steerable outer sleeve 324 and
extend through holes 374 in one or more rings 370, as shown in FIG.
10, before terminating in attachment to the steerable outer sleeve
324 directly or to one of the rings 370 placed to anchor the
tension cables 372. Including a number of the rings 370 along the
length of the steerable outer sleeve 324 and passing the tension
cables 372 avoids weakening the strength of the tension cable 372.
The rings 370 can be laser welded to the steerable outer sleeve
324.
It will be understood that the tension cables 372 can be routed
through lumens in the wall of the steerable outer sleeve 324,
through an inner lumen of the outer sleeve 324, along grooves
formed on an interior or exterior surface of the steerable outer
sleeve 324, or by some other structure or manner to route the
tension cables.
The articles "a," "an," and "the" are intended to mean that there
are one or more of the elements in the preceding descriptions. The
terms "comprising," "including," and "having" are intended to be
inclusive and mean that there may be additional elements other than
the listed elements. Additionally, it should be understood that
references to "one embodiment" or "an embodiment" of the present
disclosure are not intended to be interpreted as excluding the
existence of additional embodiments that also incorporate the
recited features. Numbers, percentages, ratios, or other values
stated herein are intended to include that value, and also other
values that are "about" or "approximately" the stated value, as
would be appreciated by one of ordinary skill in the art
encompassed by embodiments of the present disclosure. A stated
value should therefore be interpreted broadly enough to encompass
values that are at least close enough to the stated value to
perform a desired function or achieve a desired result. The stated
values include at least the variation to be expected in a suitable
manufacturing or production process, and may include values that
are within 5%, within 1%, within 0.1%, or within 0.01% of a stated
value.
A person having ordinary skill in the art should realize in view of
the present disclosure that equivalent constructions do not depart
from the spirit and scope of the present disclosure, and that
various changes, substitutions, and alterations may be made to
embodiments disclosed herein without departing from the spirit and
scope of the present disclosure. Equivalent constructions,
including functional "means-plus-function" clauses are intended to
cover the structures described herein as performing the recited
function, including both structural equivalents that operate in the
same manner, and equivalent structures that provide the same
function. It is the express intention of the applicant not to
invoke means-plus-function or other functional claiming for any
claim except for those in which the words `means for` appear
together with an associated function. Each addition, deletion, and
modification to the embodiments that falls within the meaning and
scope of the claims is to be embraced by the claims.
The terms "approximately," "about," and "substantially" as used
herein represent an amount close to the stated amount that still
performs a desired function or achieves a desired result. For
example, the terms "approximately," "about," and "substantially"
may refer to an amount that is within less than 5% of, within less
than 1% of, within less than 0.1% of, and within less than 0.01% of
a stated amount. Further, it should be understood that any
directions or reference frames in the preceding description are
merely relative directions or movements. For example, any
references to "up" and "down" or "above" or "below" are merely
descriptive of the relative position or movement of the related
elements.
The present disclosure may be embodied in other specific forms
without departing from its spirit or characteristics. The described
embodiments are to be considered as illustrative and not
restrictive. The scope of the disclosure is, therefore, indicated
by the appended claims rather than by the foregoing description.
Changes that come within the meaning and range of equivalency of
the claims are to be embraced within their scope.
* * * * *